Behavior modification therapy should always be the first method tried for smoking cessation in the pregnant population. If behavior modification therapy is attempted without success, NRT should be offered because of decreased risk for low birth weight and preterm delivery compared to continued smoking. Additionally, NRT does not appear to increase the risk for malformations.

The combination of poor health literacy and a complex dosing regimen/transition for rivaroxaban in venous thromboembolism (VTE) treatment may increase the likelihood of negative clinical outcomes secondary to nonadherence. The aim was to determine if a Rivaroxaban Patient Assistance Kit (R-PAK) given at hospital discharge increases proper dose transition and overall patient adherence. This prospective, randomized, controlled trial was conducted at an 859-bed academic medical center. Patients were randomized into 2 groups. In the treatment group, patients received the R-PAK with counseling at discharge, whereas patients in the control group received discharge counseling alone. In addition, patients were contacted after 21 days of therapy to assess dose transition, adherence, satisfaction, and safety. The primary outcome was percentage of patients who properly transitioned to rivaroxaban once daily on day 22. Twenty-five patients were enrolled; 12 received an R-PAK, whereas 13 comprised the control group. No difference in the baseline assessment of health literacy status was noted ( = 1.00). Proper transition to daily administration on day 22 was no different between the groups ( = .891). Adherence was reported in 99.8% of R-PAK patients and 97.65% of control patients ( = .074). Side effects were rarely reported. The use of an R-PAK for the treatment of VTE was not associated with an improvement in transition to daily administration; however, both groups had high rates of overall adherence. Pharmacist counseling/education was provided in both groups and is an important component to include in any patient discharge, especially for medications with dose transitions.

Objective To review the literature regarding the efficacy and safety of mirabegron for the treatment of overactive bladder (OAB). Data Sources A literature search was performed using MEDLINE (PubMed) prior to 12/31/2013 using the terms “mirabegron” and “randomized-controlled trial.” Study Selection/Data Extraction All published, double-blind, randomized controlled trials assessing mirabegron were included. Articles were reviewed and included if mirabegron was used as monotherapy and if the primary outcome analyzed drug efficacy. Data Synthesis The efficacy of mirabegron for the treatment of OAB has been demonstrated in the selected five randomized, placebo-controlled trials. The majority of these trials lasted 12 weeks in duration and compared various doses of mirabegron to placebo and/or tolterodine extended release (ER). Primary efficacy outcomes for the trials included mean number of micturitions per 24 hours and mean number of incontinence episodes per 24 hours. Included trials showed statistically significant reductions in both efficacy outcomes for various doses of mirabegron when compared to placebo. Conclusion Based on the trials reviewed, mirabegron has been efficacious in reducing mean number of micturitions and incontinence episodes per 24 hours, as well as improved other secondary outcomes like OAB symptoms and quality of life measures. Common adverse drug events seen with mirabegron include: hypertension, nasopharyngitis, urinary tract infections, headache, constipation, upper respiratory tract infection, arthralgia, diarrhea, tachycardia, abdominal pain, and fatigue. Given the efficacy and safety data currently available, mirabegron represents a reasonable alternative to antimuscarinics for patients with OAB.Future studies are needed to determine the utility of mirabegron for OAB in a variety of demographics.

Neither HPV vaccine should be routinely administered during pregnancy. If a pregnancy occurs midseries, the remaining vaccines should be given after pregnancy completion. Further studies are required to determine actual risk.

Available data suggest promising strategies to identify WUS patients who may benefit from thrombolysis. Once on-going trials are complete, there may be sufficient information to redefine tPA eligibility for previously excluded patients.

Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of beta cells, resulting in a loss of insulin production. Patients with T1D carry a substantial disease burden as well as substantial short-term and long-term risks associated with inadequate glycemic control. Currently, treatment mainly consists of insulin, which only treats the symptoms of T1D and not the root cause. Thus, disease-modifying agents such as anti-CD3 monoclonal antibodies (mAbs) that target the autoimmune destruction of beta cells in T1D would provide significant relief and health benefits for patients with T1D. This review summarizes the clinical evidence regarding the safety and efficacy of anti-CD3 mAbs in the prevention and treatment of T1D. Summary A total of 27 studies reporting or evaluating data from clinical trials involving otelixizumab and teplizumab were included in the review. Anti-CD3 mAbs have shown significant benefits in both patients at high risk for T1D and those with recent-onset T1D. In high-risk populations, anti-CD3 mAbs delayed time to diagnosis, preserved C-peptide levels, and improved metabolic parameters. In recent-onset T1D, anti-CD3 mAbs preserved C-peptide levels and reduced insulin needs for extended periods. Anti-CD3 mAb therapy appears to be safe, with primarily transient and self-limiting adverse effects and no negative long-term effects. Conclusion Anti-CD3 mAbs are promising disease-modifying treatments for T1D. Their role in T1D may introduce short-term and long-term benefits with the potential to mitigate the significant disease burden; however, more evidence is required for an accurate assessment.

Background: Basaglar, insulin glargine (BGlar; Eli Lilly, Indianapolis, IN), a follow-on biologic, was developed after the patent for Lantus, insulin glargine (LGlar; Sanofi-Aventis, Paris, France) expired. Objective: To compare the dosing and hemoglobin A1C (A1C)-lowering effects of BGlar compared with LGlar in a real-world setting. Methods: Adult patients, at 5 clinics, with type 1 (T1DM) or type 2 diabetes mellitus (T2DM) who were converted from LGlar to BGlar were included in this retrospective observational study. The primary outcome compared mean basal insulin dose (U/d) from the date of conversion to 6 months. Basal insulin and total daily insulin doses were also compared from baseline to 3- and 12-months postconversion, as also change in A1C, body weight, and estimated monthly acquisition costs of basal insulin. Results: Of the 225 patients included, 56% were male, and 81% had T2DM. The mean conversion dose (U/d) of LGlar was 46.3 ± 32.7. There was no significant difference in the mean BGlar dose (U/d) at 6 months (45.9 ± 33.5; P = 0.52), nor was there a statistical difference at 3 or 12 months. There were no significant differences in change in A1C at any time point. The estimated monthly acquisition cost of BGlar was significantly less than that for LGlar at conversion ($286 vs $341, P < 0.001) and 6 months ($290 vs $351, P < 0.001) respectively. Conclusion/Relevance: The results of this retrospective study suggest that BGlar resulted in similar glycemic outcomes compared with LGlar in a real-world setting and may be a preferable option in a value-based health care environment.

Based on evidence of decreased microvascular and macrovascular complications, the current American Diabetes Association (ADA) guidelines recommend as goals an A1C of < 7%, blood pressure of < 130/80 mmHg, and LDL cholesterol of < 100 mg/dl.1 It has been demonstrated that the recommended goals can be achieved with formal education, routine appointments, and close telephone follow-up. 2 However, in the current health care environment with time constraints on primary care providers and common patient follow-up intervals of every 3 months, these proven methods are impractical. Thus, attainment of glycemic control in the primary care setting has, historically, been suboptimal. 3,4 It has been demonstrated that diabetes-focused pharmacist care can improve outcomes, including reductions in A1C, improvement in lipid parameters, and increased adherence to preventive care guidelines. 5-10There are fewer data evaluating the impact of pharmacist-managed insulin titration.Achieving glycemic control presents additional unique challenges in low-income minority patient groups. Some barriers encountered in this population include misconceptions about health and food, inability to afford more healthful dietary options, and a low level of health literacy. A recent cross-sectional study 11 found that more than half of lowincome, minority patients surveyed believed that a normal glucose level Purpose. To assess the impact of a pharmacist-managed insulin titration program on achieving clinical goals in an underserved population with diabetes.Methods. The study included 35 subjects followed in a pharmacistmanaged insulin titration and 35 matched control subjects. Control subjects were followed under standard procedures within the same clinic and were matched for age, titration time frame, and insulin regimen. The primary outcome was change in A1C between the two groups at 6 months. Secondary outcomes included change in A1C within groups at 3, 6, 9, and 12 months, as well as the proportion of subjects attaining a goal A1C of < 7% and adhering to preventive care recommendations.Results. Between-group comparison demonstrated a significant absolute difference in mean change in A1C at 6 months favoring pharmacist management (0.9%, 95% CI 0.2-1.6, P = 0.009). Within-group comparisons demonstrated significant A1C reduction from baseline at 6 months (−1.1%, 95% CI −1.7 to −0.4, P = 0.002), 9 months (−1.4%, 95% CI −2.0 to −0.7, P < 0.001), and 12 months (−1.3%, 95% CI −2.0 to −0.5, P = 0.001) in the pharmacistmanaged group with no significant changes observed in the control group.Conclusion. Pharmacist-managed insulin titration resulted in significant improvement in glycemic control compared to standard care in an indigent population.